Project Manager, Validation - QC Analytical Lab Equipment Installation IQ/OQ/PQ

Location: Lansing, MI

Job Description

Project manager to oversee and report on the installation and qualification activities of Analytical Lab Equipment (listed below) IQ/OQ/PQ.
Instrument Category System
Atomic Absorption
Water TMC Pumps with the associated new filter
MCS (Endotoxin) Software Upgrade
MCS Equipment (x2)
GlobalVision System
Select Agent Refrigerator (CTU)
Artel Calibrators
Refrigerator (CTU)
Plate Reader (x2)
The expectation for the project manager is to ensure that milestones and associated deliverables from internal clients meet the expected delivery date and time. Experience with conducting meetings (both business and technical) with client and with client's suppliers. Experience with interactions face to face or via WEB (Microsoft Teams) meetings desired.
 Experience conducting technical meetings: The forum and frequency are yet to be determined for the project.
 Experience conducting business meetings for purpose of scheduling work: The scope will be in reference to required multi-departmental resourcing and scheduling. The agenda will be generated by the client or the assigned Project Manager and will account for processes impacting development and testing which may impact the safety of personnel due to COVID 19 safety requirements. Daily meetings with personnel assigned to specific equipment will required in order to track required resources for onsite implementation.
 Experience generating project schedule reports showing critical path tasks. Schedule reports shall be presented in Gannt format with frequent updates for completion of critical path tasks.
 Experience with Critical Path tasks: Validation Project Plan, Vendor IOQ, System Configuration / DS, Validation Summary Report.
 Communication of resource constraints impacting the critical path progression (e.g. COVID exposure, missing system documentation, components and/or system installation/configuration problems). All potential issues to be immediately communicated to client and mitigation/changes approved by client.
 Experience with creating and using Dashboard reports (to be generated on a weekly basis to give a high-level report on progress and major risks to project completion).
 Experience with project change management. Changes in the Scope of the Project, update to Purchase Order when necessary (cost or timing changes), notification of stakeholders if replacement / selected new instrument are identified during the project, management of timeline changes based on vendor availability and identified system milestones, updating Gantt chart and reporting with changes.
Experience managing projects for analytical instrument qualification/validation that include generation of the GMP documentation below related to procedures and work instructions.
• Validation Project Plan for each equipment. (Template to be provided).
• User Requirement Specification creation and/or revision. (Template to be provided).
• Design Specification documentation: A document that specifies what hardware, software, network and storage locations (Class C Systems) are required to use in a Current Good Manufacturing Practice (cGMP) environment.
• Installation and Operational Qualification
• Performance Qualification
• Trace Matrix and Validation Project Plan GAP assessment
• Validation Summary Report
• System/Equipment Assessment for data retentive 21 CFR Part 11 compliant systems.
• Creation of Preventative Maintenance and Calibration in accordance with industry practices and vendor recommendations for lifecycle activities.
•All United States Pharmacopeia (USP) category C / GAMP 3 through 5 systems with data retention required for use meet current industry standards for Data Integrity per FDA Data Integrity Guidance 2018 in compliance with Policies and procedures.
•Follow FDA and USP requirements for qualification of Analytical Equipment.
•Current Good Manufacturing Standards (cGMP)
•Computerized systems meet 21 CFR Part 11 Compliance

•Ensuring Data Retentive Systems have controls in place to meet 21CFR Part 11 compliance.
•Laboratory equipment qualification with PM and Calibration defined for implementation.

About Azzur

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success.  We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.  Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

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